Field of the Invention
The invention relates to a set of sharps and a container therefor used in catheterization by the Seldinger technique.
The Seldinger technique (named after a Swedish physician) is a method of percutaneous insertion of a catheter into an artery or a vein. Basically, the vessel in question is punctured with a needle, a thin wire is threaded through the needle and into the vessel. After the needle is withdrawn, a catheter is inserted over the wire. Finally, the wire is withdrawn and the catheter is in place.
A typical Seldinger insertion requires the handling of six different sharps. The protection of medical personnel while handling a needle attached to a conventional syringe during the process of removing the needle from the conventional protective sleeve or cap covering the needle or replacing the needle, after use, into the protective sleeve and for subsequent removal of the cap and needle from the barrel of the syringe for temporary storage or proper disposal has become increasingly important.
With the recognition of the existence of the HIV virus and the resulting development of the Acquired Immune Deficiency Syndrome (AIDS) the use, handling and disposal of hypodermic needles of the type attached to syringe type devices has become increasingly dangerous. Previously the medical profession was generally relaxed in the handling of such instruments as well as the overall disposal of the needle portion thereof after use. It is of course well recognized that various types of gloves, while generally protecting exposure of the covered skin to blood or other fluid from the body does not protect medical personnel from being inadvertently exposed to contaminated needles particularly when such needles are being replaced back into a conventional protective cap or sleeve after use and immediately prior to disposal.
Numerous attempts exist in the patented prior art to overcome such problems and provide adequate protection to medical personnel involved in such medical activities.
U.S. Pat. No. 5,078,692 to Cuprak, for instance, discloses a device for gripping, holding or stabilizing an article such as a needle secured to a hypodermic syringe and includes a hollow tubular stem which tapers to a graduated or step smaller tubular end or lumen toward the bottom. This bottom area has a flexible resilient spiral tail extending from the bottom end to facilitate various sized articles, objects or items being held by the non-dominant hand while performing certain work functions with the other hand and accordingly protecting the utilizing hand while performing such work functions.
U.S. Pat. No. 4,826,488 to Nelson, for instance, discloses a guard for hypodermic syringe needles which keeps the extremities and particularly the hands away from the syringe thereby attempting to prevent accidental punctures with contaminated needles. The needle guard includes a cylindrical cap which slides over the needle having a manipulating device to remove and replace the guard while keeping the hands away from the needle.
U.S. Pat. No. 5,098,404 to Collins discloses an apparatus for storing prior to and after use, a hypodermic syringe which includes a hypodermic needle such that the chance of the spread of infection of diseases is minimized. The device includes an elongated barrel with a stopper or penetrable cover through which the needle of the syringe structure is initially placed. After use the entry into the hollow chamber of the elongated tube is reversed and there is an antiseptic or like substance saturated within a plug or closure at the opposite end. A funnel like object or flared receiving portion is used to guide the needle into the interior of the tubular portion.
U.S. Pat. No. 5,078,695 to Farrar, Jr. discloses a needle cap holder of a syringe formed of a compressible material and having a central portion tapered inwardly from the top and bottom. The device is a central vertical cylindrical opening for receiving a needle cap of the syringe and it also includes a concaved bottom portion.
U.S. Pat. No. 5,092,852 to Poling discloses a safety syringe including a protective cap resiliently held on a needle of the syringe for preventing injuries, through punctures to someone handling the device. A locking tab is detachably clamped on a needle holder of the needle and at least a protrusion formed on the needle holder operably engages a protrusion groove formed in a needle sleeve. Removable of the locking tab from the needle holder and upon an inward depression of the needle holder and the needle into the needle sleeve engages the protrusion on the needle holder with the groove formed on the sleeve. The needle will therefore be permanently locked into the needle sleeve for a safer disposal of the needle after use.
Based on the above it is apparent that numerous attempts have been made in the medical profession in order to devise an efficient yet relatively inexpensive structure for the protection of the medical personnel's hands when utilizing needles, particularly needles associated with hypodermic syringes or like assemblies. Of particular danger is the period after use when the needle is "contaminated". Before disposal it is now required that the needle be replaced into a conventional protective cap or sleeve. The needle is "locked" in such sleeve and in certain instances may be removed from the barrel portion of the syringe for disposal. The past has indicated that if no protection device is utilized to accomplished the above set forth procedures, numerous punctures result which in turn results in contamination of medical personnel with the HIV virus or other contagious diseases. There is therefore a recognized need in the industry for a low cost device or assembly which adequately protects the personnel handling such hypodermic syringe structures wherein the device is efficient, reliable and is not complex from the standpoint of structural components or manufacture or assembly so that the cost of the overall device can be kept at an effective level. The device also may or may not be disposable or useable repeatedly.
Most cardiac catheterization is through the femoral artery with the Seldinger technique. Usually, a left side catheterization is followed by a right side catheterization. The flushing and temporary of the sharps between the two procedures is time consuming, complicated, and space and labor intensive. Also, the disposal of the plurality of sharps is cumbersome (No simple procedure kit has been previously proposed in the art).